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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: March 24, 2017

Posted 2 days ago in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: 'Sea of Despair' Engulfs White Working Class Americans: Study Low levels of education and employment are likely the root causes of rising rates of sickness and early death among white working class Americans, according to a new study. The researchers said that young adults who face those two challenges are at...

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Less Salt, Fewer Nighttime Bathroom Trips?

Posted today in Medical

SUNDAY, March 26, 2017 -- Lowering your salt intake could mean fewer trips to the bathroom in the middle of the night, a new study suggests. Most people over age 60, and many even younger, wake up to pee one or more times a night. This is called nocturia. This interruption of sleep can lead to problems such as stress, irritability or tiredness, which can affect quality of life. There are several possible causes of...

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Is MRI the 'Mammography' of Prostate Cancer Screening?

Posted yesterday in Medical

SATURDAY, March 25, 2017 -- MRI screening might greatly reduce overdiagnosis and overtreatment of prostate cancer in older men, a preliminary study suggests. Compared to the current screening method, MRI can reduce overdiagnosis of prostate cancer by 50 percent, and unnecessary biopsies by 70 percent in men over 70, Dutch researchers reported Saturday at a conference in England. Prostate cancer is common in aging...

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How Doctors Decide to Treat a Ruptured Achilles

Posted yesterday in Medical

SATURDAY, March 25, 2017 -- Whether your doctor recommends surgery for a ruptured Achilles tendon may depend partly on your age and activity level, foot experts say. The Achilles tendon is a band of tissue that runs down the back of the lower leg and connects the calf muscle to the heel bone. A rupture is a complete or partial tear of the tendon that leaves the heel bone separated or partially separated from the...

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Need More Zzzzz's?

Posted 2 days ago in Medical

FRIDAY, March 24, 2017 -- A good night's sleep is often elusive, but there are things you can do to boost the odds of getting some quality shuteye, sleep experts say. The first is to have regular bed and wake times, according to NewYork-Presbyterian Hospital sleep doctors Dr. Daniel Barone and Dr. Andrew Westwood. The doctors suggested going to sleep at the same time each night and waking up at the same time each...

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FDA Approves Symproic (naldemedine) for the Treatment of Opioid-Induced Constipation

Posted 2 days ago in New Drug Approvals

OSAKA, Japan and FLORHAM PARK, N.J. and STAMFORD, Conn., March 23, 2017 /PRNewswire/ -- Shionogi Inc. and Purdue Pharma L.P. announced today that the U.S. Food and Drug Administration (FDA) approved Symproic® (naldemedine) 0.2 mg tablets C-II as a once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic ...

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FDA Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma

Posted 3 days ago in New Drug Approvals

March 23, 2017 -- The U.S. Food and Drug Administration today granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. This is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer. “While skin cancer is one of t...

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FDA Approves Xadago (safinamide) as an Add-On Treatment for Patients with Parkinson’s Disease

Posted 5 days ago in New Drug Approvals

March 21, 2017 -- The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking. “Parkinson’s is a re...

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FDA Approves Juvéderm Vollure XC for Correction of Facial Wrinkles and Folds in Adults

Posted 6 days ago in New Drug Approvals

DUBLIN, March 20, 2017 /PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market Juvéderm Vollure™ XC, for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over the age of 21.1 In the US pivotal clinical trial, a majority (59%) of su...

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Array BioPharma Announces Withdrawal of NDA for Binimetinib Monotherapy for the Treatment of NRAS-Mutant Melanoma

Posted 7 days ago in New Drug Applications

BOULDER, Colo., March 19, 2017 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY) today announced that it has withdrawn from the U.S. Food and Drug Administration's (FDA) Division of Oncology Products 2 its new drug application (NDA) for binimetinib monotherapy for the treatment of NRAS-mutant melanoma, a rare, mutationally-driven subset of skin cancer. This action was based on thorough discussions and...

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AstraZeneca Receives Complete Response Letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for Hyperkalemia

Posted 9 days ago in New Drug Applications

March 17, 2017 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate). Sodium zirconium cyclosilicate is being developed for the treatment of hyperkalemia by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. Hyperkalemia is characterised by high potassium levels in...

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FDA Approves Merck’s Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma (cHL)

Posted 11 days ago in New Drug Approvals

KENILWORTH, N.J. March 14, 2017 --(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three ...

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Radius Health Receives Notification of PDUFA Extension for Abaloparatide-SC

Posted 2 weeks ago in New Drug Applications

WALTHAM, Mass., March 10, 2017 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS), a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, today announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of the New Drug...

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Nicox Resubmits AC-170 (Zerviate) NDA to the U.S. FDA

Posted 2 weeks ago in New Drug Applications

Sophia Antipolis, France -- March 9, 2017 -- Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced the resubmission of the New Drug Application (NDA) for AC-170, its novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis. The brand name provisionally approved by the U.S. Food and Drug...

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FDA Accepts New Drug Application and Grants Priority Review for Enasidenib in Relapsed or Refractory AML with an IDH2 Mutation

Posted 2 weeks ago in New Drug Applications

SUMMIT, N.J. & CAMBRIDGE, Mass.-- March 1, 2017 (BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) and Agios Pharmaceuticals (NASDAQ:AGIO) today announced that the U.S. Food and Drug Administration (FDA) has accepted Celgene's New Drug Application (NDA) for enasidenib (AG-221/CC-90007) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2...

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Monthly News Roundup - February 2017

Posted 3 weeks ago in Pharma Industry News

FDA Approves Once-Daily Qtern Tablets for Adults with Type 2 Diabetes The U.S. Food and Drug Administration (FDA) has cleared AstraZeneca’s Qtern (dapagliflozin and saxagliptin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP4) inhibitor treatment for adults with type 2 diabetes. This new combination agent is to be used alongside diet and exercise in those without adequate b...

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FDA Clears Test to Help Manage Antibiotic Treatment for Lower Respiratory Tract Infections and Sepsis

Posted 4 weeks ago in Pharma Industry News

February 23, 2017 -- The U.S. Food and Drug Administration today cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, such as community-acquired pneumonia, and stopped in patients with sepsis. This is the first test to use procalcitonin (PCT), a protein associated with...

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FDA Allows Marketing of Test to Identify Organisms That Cause Bloodstream Infections and Provide Antibiotic Sensitivity Results

Posted 4 weeks ago in Pharma Industry News

February 23, 2017 -- The U.S. Food and Drug Administration today allowed marketing of the PhenoTest BC Kit, performed on the Pheno System. This is the first test to identify organisms that cause bloodstream infections and provide information about which antibiotics the organism is likely to respond to (antibiotic sensitivity). The test also reduces the amount of time it takes to provide this important information,...

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Louisiana Drug and Dietary Supplement Maker Ordered to Cease Operations Due to Federal Violations

Posted 4 weeks ago in Pharma Industry News

February 21, 2017 -- On Friday, U.S. District Judge Robert G. James for the U.S. District Court for the Western District of Louisiana entered a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals, a manufacturer and distributor of drugs and dietary supplements, and its owner, Anton S. Botha, requiring the business to immediately cease operations until it comes into compliance with federal...

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Monthly News Roundup - January 2017

Posted 7 weeks ago in Pharma Industry News

Trulance Cleared by FDA for Chronic Idiopathic Constipation (CIC) The U.S. Food and Drug Administration (FDA) has approved Synergy’s Trulance (plecanatide), a uroguanylin analog for the treatment of chronic idiopathic constipation (CIC). Trulance works by stimulating secretion of bowel fluids. In studies, participants randomly received either 3 or 6 milligram (mg) Trulance tablets once a day for 12 weeks, or p...

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Lilly Announces Phase 3 MONARCH 2 Breast Cancer Study Of Abemaciclib Met Primary Endpoint Of Progression-Free Survival

Posted 6 days ago in Clinical Trials

INDIANAPOLIS, March 20, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that its MONARCH 2 trial of abemaciclib met the primary endpoint of progression-free survival (PFS). The Phase 3 study evaluated abemaciclib, a cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, in combination with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor...

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BriaCell Receives FDA Clearance to Initiate Phase I/IIa Clinical Trial of BriaVax in Patients with Advanced Breast Cancer

Posted 11 days ago in Clinical Trials

Berkeley, CA and Vancouver, BC – March 15, 2017 – BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV: BCT) (OTCQB: BCTXF), an immuno-oncology focused biotechnology company with a proprietary vaccine technology, today announced that the U.S. Food and Drug Administration (FDA) has provided clearance to initiate an open-label Phase I/IIa clinical trial of BriaVaxTM in patients with advanced breast cancer. B...

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FDA Grants Orphan Drug Designation to Boehringer Ingelheim’s Investigational Anti-CD33 Monoclonal Antibody BI 836858 for Treatment of Myelodysplastic Syndromes

Posted 2 weeks ago in Clinical Trials

Ridgefield, Conn., March 9, 2017 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its anti-CD33 monoclonal antibody BI 836858 for the treatment of myelodysplastic syndromes (MDS). Orphan drug designation is granted by the FDA to investigational compounds intended for the safe and effective treatment, diagnosis, or prevention of rare d...

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Servier and Pfizer Announce FDA Clearance of IND Application for UCART19 in Adult Relapsed/Refractory Acute Lymphoblastic Leukemia

Posted 2 weeks ago in Clinical Trials

March 9, 2017 - Servier, together with Pfizer Inc. (NYSE:PFE) and Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS; Nasdaq: CLLS), announced today that the U.S. Food and Drug Administration (FDA) has granted Servier with an Investigational New Drug (IND) clearance to proceed in the U.S. with the clinical development of UCART19, an allogeneic, gene-edited cellular therapy candidate to treat relapsed/refractory...

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Ocera to Announce Additional Encouraging Results from its Phase 2b STOP-HE Study of IV OCR-002 in Patients with Hepatic Encephalopathy

Posted 2 weeks ago in Clinical Trials

PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., March 08, 2017 (GLOBE NEWSWIRE) -- Ocera Therapeutics, Inc. (NASDAQ:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced it will report additional encouraging results from its Phase 2b STOP-HE study of intravenous (IV) OCR-002 in hospitalized patients with Hepatic Encephalopathy (HE) at the Cowen and...

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